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Expanding Cells, Expanding Access: Gamida Cell’s Omisirge Debuts New Donor Source For Stem Cell Transplant

 
• By Bridget Silverman

Pink Sheet’s Drug Review Profile follows the FDA’s navigation of the first expanded umbilical cord blood graft with the first indication grounded in neutrophil recovery and infection incidence data.

Drug Review Profile: Omisirge
• Source: Shutterstock

Gamida Cell Ltd.’s Omisirge (omidubicel-onlv) will be the first substantially modified cord blood-based stem cell graft source for allogeneic hematopoietic progenitor cell transplantation following FDA approval, using the Israeli company’s stem cell expansion and enhancement technology to improve clinical outcomes with umbilical cord blood grafts – and in doing so, address a significant health inequity.

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Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 
• By Bridget Silverman

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Testosterone CV Safety, From Signal To Label

 
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US FDA Review Of Akebia’s Vafseo Informed By Roxadustat, Daprodustat Safety Concerns

 
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Vadadustat's review overlapped with two other oral HIF-PH class drugs. Safety issues with FibroGen/AstraZeneca’s roxadustat drew attention during vadadustat's first-cycle review, while GSK’s Jesduvroq labeling and postmarketing requirements informed the second-cycle approval.

Akebia’s Vafseo: Japanese Postmarketing Data, Narrowed Indication Eased Liver Toxicity Worries

 
• By Sue Sutter

The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.

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Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
• By Neena Brizmohun

Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 
• By Neena Brizmohun

The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.